1. Field of the Invention
The present invention generally relates to a medical device for securing a tube to a patient, and more particularly to an improved type of anti-disconnect device that secures a tracheostomy or tracheal tube to a patient and for positively retaining a ventilator tube connector to the tube.
2. Discussion of the Prior Art
Tracheostomy and tracheal tubes are prevalently used in hospitals to assist a patient in breathing, where a tracheal tube is placed directly into the trachea or airway of a patient. A ventilator system is then connected to the tracheal tube to provide controlled ventilation. Conventional tracheal tubes consist of two portions. The first portion includes a tube-like part that is inserted directly into the airway of the patient and secured therein by a balloon inflation mechanism. The first part is known by those in the medical field as an outer cannula portion and it is usually pivotably connected to a neck plate which is designed to limit the lateral movement of the tracheal tube after its insertion within the trachea. The second portion is also tube-like and it slidably inserts within the first tubular part; this second portion is known by those in the medical field as the inner cannula portion. The inner cannula portion has one end that terminates with a universal connection piece that is cylindrically shaped. The medical industry refers to this piece as a universal connection because the outside and inside diameters of the connection piece are set to follow an industry standard so that the same fitting can be adapted to fittings provided by various manufacturers which eventually connect to the ventilator system. The universal connection piece has a set of tabs on one of its ends that allow it to snap fit onto one of the ends of the outer cannula. The other end of the universal connection piece attaches to an adapter through a friction fit. The most common type of adapter used in hospitals today is a T-shaped adapter although some hospitals may still use adapters which are shaped like a 90° elbow. The adapter, in turn, connects to the tubing that is associated with the ventilator machine.
One of the most prevalent problems with such tracheal tube and adapter arrangements is that patients are continuously moving and or being moved throughout the day and even while they sleep, thereby causing the adapter to become either fully or partially dislodged from the tracheal tube. More specifically, the movement of the patient causes the friction fit connection between the universal connection piece and the adapter to fail and pull apart. In most instances, a total disconnection of the ventilation system from the adapter would present a life-threatening situation, however, the same may be true if the ventilator only becomes partially disconnected. Therefore, it is a priority that the integrity of the connection between the ventilator and the adapter be continuously maintained until the attending nurse or respiratory therapist purposely breaks the connection for various reasons.
Various types of prior art devices have been proposed to stabilize and/or prevent the tracheal tube from disconnection with the ventilator system. Still other prior art devices have attempted to provide an anti-disconnect between the neck plate and the adapter. For example, in U.S. Pat. No. 6,047,699 to Ryatt et al., an attachment body is designed to wrap around the body of the T-shaped adapter such that a pair of laterally spaced tabs are presented for insertion through slots formed in the opposed lateral flanges of the neck plate. The tabs are then folded back onto themselves and attached thereto through provision of hook and pile material on the appropriate sides of the tabs. This device has the shortfall of requiring the health care attendant to thread the tabs through the small slots of the neck plate while it is pressed tightly against the patient such that the attendant has to push or pull on the patient's neck and skin in order to slip the tabs around the backside of the neck plate. Such action creates unnecessary discomfort for the patient while being a very frustrating and time consuming endevor for the health care attendant. Furthermore, because the tabs are rather insubstantial in size, they easily become unhooked from themselves as the patient moves, thereby defeating the purpose of the device. Other prior art devices have also attempted to secure a form of an anti-disconnect device directly to the neck plate, as in U.S. Pat. No. 5,282,463 to Hammersley and U.S. Pat. Nos. 5,975,080, 6,009,872 and 6,105,573 to Delaplane et al. However, a common problem with each of those devices is that the anti-disconnect means, which attaches to the neck plate, slides off one of the lateral ends of the neck plate when the patient turns his head in a lateral direction. Still other prior art devices have employed hook and loop material strapping systems (Velcro®) to attach to the neck band that wraps around the neck of the patient for securing the neck plate thereto. The strap type of devices have been favored by heath care attendants because of their expediency and simplicity and examples of those types of devices can be found in U.S. Pat. No. 6,822,509 to Kron, and U.S. Pat. No. 5,839,457 to Briggs III and U.S. Pat. No. 5,357,952 to Schuster et al. Although these devices are much simpler, they all have the common problem of the straps disconnecting from the neck band during patient movement because there is no provision for restraining the straps against the neck band during patient movement. It should be appreciated that during patient movement, the tension on each of straps creates a tendancy to pull the hook material off the loop material. Furthermore, the dimensional size of the straps does not provide enough contact area between the hook and loop material to continuously maintain the connection. Therefore, from the above discussion of prior art devices, it should be understood that most tracheal tube securing devices do not provide adequate means for stabilizing the position of the transverse portion of the adapter to prevent undesired rotation or other movement of the adapter as the patient moves, thus a partial or complete disassociation with the ventilator results.
Heretofore, the ability to retain the T-shaped and 90° elbow adapters in continuous connection with the universal connection piece has been highly limited. Ideally, it would be desirable to provide an improved tracheal anti-disconnect device that overcomes the deficiencies of the prior art devices by providing an anti-disconnect device that is comfortable to the patient, easy to apply and remove, and which maintains the integrity of the connection between the adapter and the universal connection piece.